Kornimate/medical-research-clean huggingface dataset:
firmagon® intensive drug monitoring

Conditions: Prostate Cancer

Summary: to evaluate the safety profile of firmagon® (to fulfill the regulatory authority's requirement of intensive drug monitoring in chinese participants with prostate cancer need androgen deprivation therapy \[adt\] treated with firmagon®). study design this study is a multi-center, single-arm, non-interventional, prospective study among chinese participants with prostate cancer in need of adt, receiving treatment with firmagon®. this program provided the minimum 6 doses and maximum 12 doses of firmagon® to enrolled participants during one-year follow-up. participants who met the inclusion criteria would or were accepting at least 6 self-financed doses of treatment in a hospital. participants should return to the hospital for medical assessment every three months. the prescription of 6 (3 doses × 2 times) self-financed doses will be given by doctors after assessment, and the direct-to-participant pharmacy will distribute firmagon® to eligible participants (participants should bring the prescriptions and the last firmagon® boxes to get other doses). all enrolled participants were followed up to collect safety information for one year from the 1st dose unless withdrawal of informed consent form, discontinuation for 2 months, lost to follow-up, death, or termination due to other reasons, whichever came first.


Eligibility criteria:
inclusion criteria: * diagnosed with prostate cancer and in need of adt * decision made to prescribe firmagon® prior to enrollment * willingness and ability to provide written informed consent * the participants are taking the marketed drug firmagon® exclusion criteria: * not signed informed consent * any participants who are unsuitable to participate in this study because of any other reasons will not be qualified to participate in this study.
whole brain radiotherapy (wbrt) versus stereotactic radiosurgery (srs) for 4 upto 10 brain metastases

Conditions: Neoplasm Metastasis

Summary: recently stereotactic radiosurgery (srs) in 5 up to 10 brain metastases showed to have equal survival as in 2 up to 4 brain metastases. whole brain radiotherapy (wbrt) is currently the gold standard for patients with more than 3 brain metastases, but has significant side effects. in this prospective randomized phase iii trial wbrt is compared to srs for patients with 4 up to 10 bm.

dutch guideline advices stereotactic radiosurgery (srs) for patients with 1 up to 3 brain metastases (bm) and whole brain radiotherapy (wbrt) for patients with 4 or more bm. the interim analysis from the quartz study showed that wbrt did not provide benefit in quality of life nor survival over best supportive care. wbrt has significant side effects, such as hair loss, fatigue, and cognitive dysfunction which may impair quality of life. a recently published study showed that srs in patients with 5 up to 10 bm had a comparable survival to patients treated with 2 up to 4 bm. many systemic therapies do not have a satisfactory intracranial response, because of the blood-brain barrier. the potential advantages of srs i.e, limiting radiation doses to the uninvolved brain and a high rate of local tumour control by just a single treatment. next logic step would be to compare wbrt with srs alone in patients with 4-10 bm and evaluate whether srs is superior to wbrt with regard to qol.

Eligibility criteria:
inclusion criteria: * minimal 4 up to a maximum of 10 bm on diagnostic mri scan * max diameter of single gtv 2.5cm * max cumulative gtv of 30cm3 * karnofsky performance status ≥ 70 * any solid primary tumour. small cell lung carcinoma, germinoma, and lymphoma are excluded * ability to provide written informed consent exclusion criteria: * contra-indication for mri * prior treatment for bm (i.e. surgery, srs or wbrt) * concurrent use of systemic therapy * maximum cumulative gtv of more than 30cm3 on planning-mri * more than 10 bm on planning-mri * a brainstem metastasis with a ptv of more than 20 cm3
a study of apixaban in patients with atrial fibrillation, not caused by a heart valve problem, who are at risk for thrombosis (blood clots) due to having had a recent coronary event, such as a heart attack or a procedure to open the vessels of the heart

Conditions: Acute Coronary Syndromes

Summary: the purpose of this study is to determine if apixaban is safer than a vitamin k antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. all patients would also be taking a class of medicines called p2y12 inhibitors (such as clopidogrel/plavix) and be treated for up to 6 months. the primary focus will be a comparison of the bleeding risk of apixaban, with or without aspirin, versus a vitamin k antagonist, such as warfarin, with or without aspirin.

patients will be recruited from either inpatient coronary care or general medical units, or recruited from outpatient cardiology offices. masking: apixaban: open label. vka: open label. acetylsalicylic acid film coated tablet: double blinded. placebo matching acetylsalicylic acid film coated tablet: double blinded.

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. in addition, subjects must have had an acute coronary syndrome or percutaneous coronary intervention with a stent within the prior 14 days * planned use of antiplatelet agents for at least 1 to 6 months * males and females ≥ 18 years of age * women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug exclusion criteria: * conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve) * severe renal insufficiency (serum creatinine \> 2.5 mg/dl or a calculated creatinine clearance \< 30 ml/min * patients with a history of intracranial hemorrhage * patients have had or will undergo coronary arterial bypass graft (cabg) for their index acute coronary syndrome (acs) event * patients with known ongoing bleeding and patients with known coagulopathies * any contraindications or allergies to vka, apixaban, or to intended p2y12 antagonists or to aspirin
secondary prevention of coronary events after discharge from hospital (spread)

Conditions: Acute Coronary Syndrome

Summary: this is a randomized, open trial comparing post discharge interventions by community health workers (chw) to standard care in acute coronary syndrome (acs) patients. this trial will be conducted in 10 hospitals in india/different parts(both secondary and tertiary care). a total of 800 patients will be recruited, with equal allocation to spread interventions and control groups (usual care)

inclusion criteria: consenting patients being discharged after an acute coronary event such as unstable angina, acute myocardial infarction, or after coronary intervention (cabg surgery or pci). exclusion criteria: patients with other terminal/ debilitating illness, (e.g., advanced cancer, disabling stroke) those not expected to survive for the study duration, those with dementia and psychiatric illness or patients unlikely to comply with study requirements, including regular follow up. outcome measures: 1. feasibility 2. difference in adherence to specific medications for secondary prevention of cad (coronary artery diseases) compared to the control group, at one year.

Eligibility criteria:
inclusion criteria: * consenting patients being discharged after an acute coronary event such as unstable angina, acute myocardial infarction, or after coronary intervention (cabg surgery or pci). exclusion criteria: * patients with other terminal/ debilitating illness, (e.g., advanced cancer, disabling stroke) those not expected to survive for the study duration, those with dementia and psychiatric illness or patients unlikely to comply with study requirements, including regular follow up

Keywords: post discharge intervention adherence compliance community health worker
the effectiveness of neuropsychological rehabilitation in young dyslexic adults

Conditions: Dyslexia

Summary: the purpose of this study is to determine whether individual and/ group based neuropsychological rehabilitation focused on psychoeducation and teaching compensatory strategies has positive effects on the psychosocial wellbeing and perceived cognitive deficits in dyslexic young adults. the hypothesis is that both individual and group based neuropsychological rehabilitation show positive effects on the psychosocial wellbeing and perceived cognitive deficits. another purpose of this study is to evaluate weather individual and group based neuropsychological rehabilitation have different kind of effects on the wellbeing of the participants and weather either one of the rehabilitation formats is more effective than the other.

background: untreated dyslexia causes problems for individuals in studies, work and employment. high quality research on the best and most cost-effective rehabilitation methods is needed. objective: to study whether neuropsychological rehabilitation improves the psychosocial wellbeing and perceived cognitive deficits in dyslexic young adults and to evaluate potential differences between individual and group based neuropsychological rehabilitation. methods: altogether 120 young adults diagnosed with dyslexia are randomized either to one of the intervention groups (individual neuropsychological rehabilitation / group neuropsychological rehabilitation) or to a control group which will receive either one of the interventions after a 5 month waiting period. all the study subjects are assessed with a short neuropsychological test battery as well as self-rating questionnaires evaluating mood, qol, perceived cognitive deficits, and the impact of the learning disability at baseline, after five months (immediately after interventions or control period) and after 10 months. after 20 months a shorter follow-up using only self-ratings will be done via mail. subjects in the intervention groups are offered neuropsychological rehabilitation in 12 sessions conducted once a week or once in two weeks during five months. subjects in the control group do not receive any intervention for the first five months. results: the effects of interventions on psychosocial wellbeing and perceived cognitive deficits are evaluated using appropriate statistical procedures and comparing the differences between the interventions groups and the control group. the present status: all the interventions are completed, follow-up data is still beeing collected

Eligibility criteria:
inclusion criteria: * clinical diagnosis of dyslexia * age 18-35 * problems in studies, work or employment relating to dyslexia * subjective and objective need for rehabilitation * the native language is finnish exclusion criteria: * other neurological condition than dyslexia * other learning disabilities than dyslexia * overall weak cognitive capacity * psychiatric diagnosis * severe depression * alcohol or drug abuse * neuropsychological rehabilitation received at the age of 16 or later
prevalence of self-disclosed knee trouble and use of treatments among elderly individuals

Conditions: Knee Osteoarthritis; Survey, Family Life; Complementary Therapies; Pain

Summary: although knee pain is prevalent among community-dwelling older adults, little is known about how people in general handle their pain. we will conduct a survey to explore how knee pain affects people's lives and which treatments or self-management strategies they have chosen (or are being offered), and how these interact concerning pain reduction and maintenance of function.

although knee pain is prevalent among community-dwelling older adults and frequently leads to consultation in primary care, little is known about how people in general manage their knee pain. treatments of knee osteoarthritis include a variety of non-pharmaceutical, medical, and surgical interventions with highly individual and inconsistent results and with the possible exception of a longer lasting weight reduction, none of the non-surgical treatments have been able to demonstrate long-lasting effect on pain or disability. it is well recognised that patient participation in handling of disease creates better compliance and satisfaction with pharmacological treatment. another option for taking active part in self-management is the use of complementary and alternative medicine (cam). despite their popularity and effect, there is currently no overview of the actual extent of cams used for knee pain and disability at a population level, and most cams remain to be studied scientifically for efficacy. the incidence of knee oa shows a steep increase at age above 60 years. furthermore, after this age an increasing prevalence of disablement to knee trouble is encountered. to prevent this development, measures must be sought to alter the course of knee oa. by asking people about how knee pain affects their life, which treatments or self-management strategies they have chosen (or are being offered), and how these interact for the reduction of pain and maintenance of function, new knowledge will be gained about the preferences and perceived effectiveness of treatments at large. the information gained will enable the prioritising of research on interventions to be tested and will align this with the primary concerns and interests of the population. this will subsequently lead to better guidance of patients by the health care providers, and will aid decision makers in choosing feasible health care policies and strategies.

Eligibility criteria:
inclusion criteria: * between 60-69 years of age * citizen in the community of frederiksberg exclusion criteria: • no formal exclusion criteria but unability to understand/answer our questionnaire is per se an exclusion criteria

Keywords: knee osteoarthritis pain complementary therapies survey questionnaire
interphase gap in biphasic stimulation in dbs for et

Conditions: Essential Tremor

Summary: deep brain stimulation (dbs) is a well established therapy in medication-refractory essential tremor (et). since the inception of dbs, cathodic pulses are used. recent work suggests that biphasic pulses influence the therapeutic window when compared to cathodic pulses, when tested acutely. animal studies and work from cochlear implants, show that the use of an interphase gap, influences the generation of action potentials. in this study, the goal is to investigate the use of an interphase gap in biphasic pulses in dbs for et patients.


Eligibility criteria:
inclusion criteria: * patients with essential tremor treated with vim-dbs * normal impedances of dbs circuit * signed written informed consent exclusion criteria: * active psychiatric disease or active alcohol or drug abuse * dementia * history of recurrent or unprovoked seizures * relevant comorbidities that influence objective clinical assessment * pregnancy
new modality for post covid syndrome patients

Conditions: Post Covid Syndrome

Summary: coronavirus (19) is a pandemic that affects many countries allover the world. many patients experienced symptoms as dyspnea and fatigue after their recovery from coronavirus . these symptoms appear to occur regardless the severity of the infection. in addition, many studies reported change in the inflammatory status and immunity in post covid patients. laser acupuncture is a painless noninvasive modality that is used in treating many diseases. laser acupuncture appear to have a role in relieving symptoms, altering inflammatory status and boosting immunity in post covid patients.


Eligibility criteria:
inclusion criteria: * age will be ranged from 30 to 40 years * patients were diagnosed as covid 19 by polymerase chain reaction test using nasopharyngeal swap * patients will be negative polymerase chain reaction test (pcr) with symptoms of dyspnea and fatigue. * patients will be recruited after 2 weeks post the negative pcr * patients who want to participate and complete the study till the end exclusion criteria: * patients with photosensitivity * pacemaker plantation pregnant women * bmi more than 30kg/m2 infection or inflammation at the site of acupuncture laser malignancy uncontrolled diabetes psychiatric disorders or mental retardation
epo-bul-01 - study of the optimization of anemia management of eprex (epoetin alfa) in predialysis patients with chronic renal failure

Conditions: Chronic Renal Failure

Summary: the purpose of the study is to evaluate the effectiveness, safety and clinical outcome of epoetin alfa with dosing regime in accordance with summary of product characteristics in the treatment of anemia in predialysis.

open-label, non-randomized, multicenter study for anemic patients with hemoglobin \<or=11 g/dl. the dose of epoetin alfa is the routine dosage regimen and is in accordance of the approved smpc. that's why the study had in general two phases - first period: subcutaneous administration and second period:intravenous administration. the evaluation is made in 4 visits:baseline, 2 month (visit 1), 4 month (visit 2), 6 month (visit 3), 9 month (visit 4). echographic evaluation - on baseline visit, visit 3 and visit 4.baseline visit - weight, arterial pressure, hemoglobin, hematocrit, erythrocytes, middle cells volume, middle cells hemoglobin, middle cells hemoglobin concentration, transferrin, creatinine, clerans, visit1, visit 2, visit 3, visit 4 - hemoglobin, hematocrit, erythrocytes, middle cells volume, middle cells hemoglobin, middle cells hemoglobin concentration. the dosage is in routine dosing regimen, the starting dose of epoetin alfa is 50 units/kg body weight. the maintaining dose depends on hematological results. administration - subcutaneous (during the first period), intravenous (second period). duration of the study - 9 months.

Eligibility criteria:
inclusion criteria: * patients with hb\<or= 11g/dl * females - using adequate contraceptive method exclusion criteria: * patients with uncontrolled or severe cardiovascular disease, including recent myocardial infarction, uncontrolled hypertension or congestive heart failure * treatment within the previous 6 months with epoetin alfa or any erythropoietin, known hypersensitivity to the product or to any of the ingredients * patient not in line with the approved smpc

Keywords: chronic renal failure left ventricular hypertrophy epoetin alfa
cardiovascular rehabilitation early after stroke using feedback-controlled robotics-assisted treadmill exercise

Conditions: Stroke; Cardiovascular Diseases

Summary: the propose of this study is to evaluate the feasibility and the clinical efficiency of feedback-controlled robotics-assisted treadmill exercise (rate) technology for cardiovascular rehabilitation early after stroke. the investigators hypothesize that feedback-controlled rate might be suitable and effective to improve cardiovascular fitness and functional carryover in non-ambulatory individuals with sub-acute stroke.

for detailed info: stoller o, de bruin ed, schuster-amft c, schindelholz m, de bie ra, hunt kj. cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomized controlled pilot trial. trials. 2013 sep 22;14(1):304.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of an initial supratentorial stroke * ≤20 weeks post stroke at intervention onset * age ≥18 years * functional ambulation category (fac) ≤3 * ability to understand the procedures and provide informed consent exclusion criteria: * contraindications for exercise testing outlined by american college of sports medicine (acsm) * contraindications for rate according to the manufacturer * concurrent neurological disease * concurrent pulmonary disease * history of dementia

Keywords: rehabilitation robotics-assisted treadmill exercise aerobic capacity exercise testing
impact of hospitalization on high-sensitivity cardiac troponin t concentrations depending on disease severity

Conditions: Non-cardiac Disease

Summary: we aim to examine, whether hospitalization is associated with higher high-sensitivity cardiac troponin t (hs-ctnt) serum concentrations in patients without a cardiac disease.

high-sensitivity cardiac troponin t (hs-ctnt) values will be obtained in hospitalized patients a) without a diagnosed or suspected cardiac disease, and b) with an acute medical condition that is not commonly associated with an increase of hs-ctnt concentrations. as a reference, a second sampling of blood for an analysis of the hs-ctnt serum concentration will be obtained in the same patients after discharge (60 days after hospitalization).

Eligibility criteria:
inclusion criteria: * hospitalization due to a non-cardiac disease * age ≥ 50 years exclusion criteria: * diagnosed or suspected cardiac disease * acute medical conditions commonly associated with a myocardial injury (e.g. circulatory shock, sepsis, pulmonary embolism, cerebral infarction, acute renal failure)
neurobiomarker for prism adaptation treatment response

Conditions: Perceptual Disorders; Stroke; Biomarker

Summary: preliminary data will be collected about which individuals with spatial neglect from right hemisphere stroke (aiming vs perceptual neglect) improve with prism adaptation training and if there is a particular pattern of damage in the brain that predicts both the type of neglect experienced and whether neglect is improved following prism adaptation training

for preliminary data, twelve individuals with right hemisphere stroke and spatial neglect will participate. after pretesting for type of neglect and its severity, they will have an mri with diffusion tensor imaging (dti). then they will complete 10 sessions of prism adaptation therapy and complete neglect post-testing. response to prism adaptation therapy will be assessed by comparing neglect scores pre- and post-training. traditional lesion mapping, structural and functional lesion disconnectivity analyses, and tract-based spatial statistics of dti measures will be used to examine whether any patterns of damage/dysfunction are related to a diagnosis of aiming neglect and response to prism adaptation therapy.

Eligibility criteria:
inclusion criteria: * 1) within 1 month of right hemisphere stroke 2) suspected of having unilateral spatial neglect 3) able to provide consent 4) likely to remain in rehabilitation for 10-12 days or willing to return to the university to complete 10 sessions of treatment and post-treatment testing 5) able to have an mri 6) will be or has been admitted to the craig h. neilson rehabilitation hospital for rehabilitation or is able to come to the craig h. neilson rehabilitation hospital for prism adaptation therapy sessions. 7) age 18-90 years 8) able to sit in a wheelchair or other chair for 1 hour 9) able to point straight ahead and hold a pen with right hand exclusion criteria: * 1) other neurologic, medical that would interfere with ability to complete the testing or training 2) no uncorrected visual or hearing problems, other than hemianopsia 3) contraindications to mri 4) unable to provide consent due to significant aphasia or cognitive impairment

Keywords: stroke prism adaptation therapy spatial neglect